Quality Engineer

Quality Engineer – Post-Market Surveillance & Product Reliability

Drive product quality and patient safety through data-driven problem solving. We are seeking a Quality Engineer to lead post-market surveillance activities for innovative medical devices, ensuring product performance, reliability, and compliance throughout the product lifecycle. This role is ideal for a quality professional who enjoys root cause investigations, risk management, cross-functional collaboration, and making a direct impact on patient outcomes.

What You'll Do

• Lead complaint handling and product reporting investigations from intake through closure, including risk assessment, root cause determination, and product disposition.
• Manage returned product evaluations and failure analyses to identify quality trends and product performance opportunities.
• Investigate complex product issues and coordinate testing with internal teams and external laboratories when needed.
• Analyze field performance, customer complaints, and returned product data to identify emerging quality concerns.
• Lead cross-functional reviews with Development, Manufacturing, Operations, and Quality teams to drive corrective actions and continuous improvement.
• Support CAPA activities, risk assessments, and product reliability initiatives.
• Participate in post-market risk management reviews, product performance reviews, and safety evaluations.
• Generate, review, and maintain quality system documentation, including design history file (DHF), device master record (DMR), and engineering change documentation.
• Ensure compliance with FDA regulations, ISO standards, and applicable medical device requirements.
• Support internal and external audits and provide quality expertise across the organization.

What We're Looking For

• 2+ years of experience in Quality Engineering, Design Quality, or a related medical device quality function.
• Experience with complaint handling, post-market surveillance, and field performance monitoring.
• Hands-on experience leading root cause investigations and failure analysis activities.
• Knowledge of medical device risk management methodologies, including dFMEA, pFMEA, and ISO 14971.
• Understanding of FDA Quality System Regulations and ISO quality standards.
• Strong analytical, problem-solving, and decision-making skills.
• Ability to manage multiple priorities and work independently in a fast-paced environment.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
• Strong communication and collaboration skills with cross-functional teams.

Preferred Qualifications

• Experience with electromechanical or active implantable medical devices.
• Work history in product reliability, design quality, or process quality engineering.
• Familiarity with Class III medical devices.
• ASQ certifications such as CQE, CRE, CQA, or CQM.
• ISO auditor training or internal auditing experience.
• Knowledge of IEC, EN, and other medical device-related standards.
• Experience supporting CAPA systems, post-market risk reviews, and global regulatory requirements.

Job Type & Location

This is a Contract position based out of Minneapolis, MN.

Pay and Benefits

The pay range for this position is $43.00 - $53.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Minneapolis,MN.

Application Deadline

This position is anticipated to close on Jul 15, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.